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Policy teardown · White House meeting log, the group’s own board and partner pages, FDA roster and warning letters · Sources checked October 19, 2026

Who is meeting the White House about BPC-157, TB-500 and the other peptides on Wednesday? A 2025 group whose boards include the heads of big compounding pharmacies.

FDA’s policy on letting pharmacies make BPC-157, TB-500, KPV, MOTS-c, semax and epitalon has been at the White House budget office since October 14, and its text still isn’t public.[2] The office’s meeting log lists exactly one outside meeting about it: Wednesday, October 21, at 3 PM ET, requested by the American Academy of Peptide Medicine (AAPM) and its chairman, Lee Rosebush.[1][3] AAPM calls itself a nonprofit academic society. It was founded in 2025. Its own pages list the founder and CEO of Empower Pharmacy, the CEO of Strive Pharmacy and the chairman of Thesis Pharmacy on its industry board, and name Noom and Ivím Health, two telehealth sellers of compounded weight-loss shots, as partners.[6][7][19] Its chairman also chairs the trade group that sued FDA in 2024 to keep compounded Zepbound copies legal.[10] None of that makes their case wrong. It does tell you who is in the room.

Why this matters this week

Semafor reported early Monday, October 19, that AAPM “is slotted to meet with the Office of Management and Budget on Wednesday” about the pending policy.[3] Within hours, a Hims & Hers stock account on X was posting it as breaking news.[4] The meeting is real and on the public record.[1] Most coverage stops at the name of the group. Here is what the group’s own pages, and FDA’s, say about who it is.

The short answer

The group asking for the meeting is led by a pharmacy-industry lawyer and a physician whose company distributes peptides. Its boards include the leaders of pharmacies and telehealth companies that would make or sell these peptides if FDA allows it.[6][7][8] Its argument is a real one: people already inject “research use only” vials from overseas, and a licensed US pharmacy would be a cleaner source.[21] What it can’t point to is human evidence that the peptides work. FDA’s own scientists recommended against all seven, and every yes vote at FDA’s July advisory meeting came from the 8 members appointed this year.[12][13][14]

What Wednesday’s meeting is, and isn’t

When a rule or policy is under White House review, outside groups can ask the Office of Information and Regulatory Affairs (OIRA) for a meeting. Under the 1993 executive order that governs these reviews, FDA must be invited, written materials go to FDA, and OIRA has to disclose the meeting publicly.[5] That is why the log shows the date, the group and the person who asked.[1] A meeting doesn’t decide anything. As of Monday morning, it was the only meeting on file for this policy. No patient-safety group, medical society or drug company had asked for one.[1]

Who the American Academy of Peptide Medicine is

Its leaders. AAPM says it was founded in 2025 and lists two leaders.[6] Lee Rosebush, a pharmacist and lawyer, is chairman. He also chairs the Outsourcing Facilities Association, a trade group for large compounding facilities.[6] In October 2024 that association sued FDA for taking tirzepatide (Mounjaro, Zepbound) off the shortage list, the step that ended the legal basis for mass-producing compounded copies. The court sent the decision back to FDA, FDA reached the same conclusion, and a federal judge later ruled for FDA and Lilly.[10] Reporters have described Rosebush as an attorney who has represented compounding pharmacies and peptide makers suing FDA over the 2023 restrictions.[13][21] The founder, Dr. Pradeep Albert, lists himself on his own site as CEO of Vesalius Longevity Labs, “peptide distribution & longevity services.”[8]

Its industry board and partners. AAPM lists four industry advisers: Shaun Noorian, founder and CEO of Empower Pharmacy, which AAPM calls “a leading producer of compounded peptide therapies”; Nate Hill, CEO of Strive Pharmacy; Jay Bhaumik, chairman of Thesis Pharmacy and BMK Pharma; and Dan DeNeui, CEO of EVEXIAS Health Solutions.[7] Its listed partners are Ivím Health, CRE8 Pharmacy, Thesis, Empower, EVEXIAS and Noom.[7] Ivím advertises compounded tirzepatide at $117 a month and compounded semaglutide at $65 a month. Noom sells a compounded semaglutide “microdose” program.[19]

Its policy board. Two former governors, Phil Bryant of Mississippi and Ricardo Rosselló of Puerto Rico, sit on its government board, alongside the chief executive of MAHA Holdings, a former senior HHS adviser, a Republican strategist and Brigham Buhler, CEO of the Ways2Well clinics. Buhler co-wrote a book on peptides with Rosebush.[7][22]

Its link to the nominations. The medical board includes James LaValle, chair of the International Peptide Society.[7] Nominations filed for that society were among those withdrawn in April, which let FDA take the peptides off its “significant safety risks” list and send them to the July advisory meeting.[13][22]

Who spoke at its September congress

AAPM held its first “PepMed” congress in Washington on September 17–18. Its published lineup, marked as a draft confirmed on a rolling basis, lists the HHS Assistant Secretary for Health, Adm. Brian Christine, and HHS senior adviser Calley Means.[9] It also lists two people tied to FDA’s advisory committee:

Speaking at a conference isn’t a conflict by itself, and we found no rule it breaks. It does show how small this world is.

How the July votes broke

Ballot grid: at FDA's July 2026 compounding advisory meeting, the 8 members newly appointed in 2026 cast 60 yes votes and 1 no on seven peptides; the other 11 members cast 0 yes, 44 no and 8 abstentions.
Member ballots as transcribed from the webcast by PeptideBase. FDA hasn’t posted official minutes. Blank cells match the topic limits on FDA’s roster.[11][12]

FDA’s compounding advisory committee voted on seven peptides on July 23–24. FDA’s staff had recommended against all seven.[13] Across the 8 roll-call ballots, the 8 members new to the committee in 2026 cast 60 yes votes and 1 no. The other 11 voters, including holdovers, the pharmacopeia, consumer and patient representatives and temporary experts, cast 0 yes votes, 44 no and 8 abstentions. All 8 abstentions came from Fensky.[12] Reporters found that most of the new members run clinics or businesses that sell peptides.[13][14] The committee’s votes are advice. FDA still has to decide.[13]

The “pharmacies are the safe source” argument

AAPM’s case is that the 2023 restrictions pushed people to overseas powder and unlabeled vials, and that licensed pharmacies that test their products are safer.[21][22] There’s evidence for the problem it describes. In the first published lab test of gray-market retatrutide vials, three vials labeled 10 mg held 5 to 19 mg.[23] A tested pharmacy product would very likely beat that.

But a pharmacy isn’t automatically clean. In September, FDA sent Empower Pharmacy, whose CEO sits on AAPM’s industry board, its second warning letter in 18 months.[17][18] After a November 2025 inspection, FDA said Empower made sterile products under insanitary conditions. It also said Empower compounded copies of Zepbound and Wegovy “regularly and in inordinate amounts,” with “significant difference” statements that were “repeated verbatim across many records, suggesting that they may be pre-generated.”[17] FDA said some of Empower’s fixes looked adequate and others weren’t documented well enough to judge.[17] The letter is about GLP-1 copies, not BPC-157. It’s still the clearest recent FDA record on whether a large compounder follows the rules.

And making a peptide cleanly isn’t the same as knowing it works. Rosebush told the committee that the bulks list carries “no requirement to prove safety or efficacy.”[20] That’s accurate. It’s also the problem FDA’s reviewers raised, since none of the six has a solid human trial behind it.[13] Pharmacies that compound under these rules also don’t have to report side effects.[20]

What to watch

Bottom line

The only group on record to lobby the White House on FDA’s peptide policy is a 2025 society whose own pages list the leaders of big compounding pharmacies and GLP-1 telehealth companies as advisers and partners. Its chairman runs the trade group that sued FDA to keep compounded Zepbound going.[1][6][7][10] Its harm-reduction argument is fair. But several of the businesses behind it would profit from the answer, and none of them can show that BPC-157, TB-500 or the others work in people.[13][21]

References

  1. Office of Information and Regulatory Affairs (OMB). EO 12866 meeting record, RIN 0910-ZD94, “Interim Access Policy for Compounding Using Certain Peptides,” HHS/FDA, Notice stage. Meeting date/time 10/21/2026 03:00 PM; Requestor: American Academy of Peptide Medicine; Requestor’s name: Lee Rosebush. https://www.reginfo.gov/public/do/viewEO12866Meeting?viewRule=true&rin=0910-ZD94&meetingId=1586023&acronym=0910-HHS/FDA. Meeting search for this RIN returned 1 record: https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-ZD94&viewRule=true. Checked October 19, 2026. (about 8:15 AM ET)
  2. Office of Information and Regulatory Affairs (OMB). Pending EO 12866 Regulatory Review, RIN 0910-ZD94, received 10/14/2026, stage: Notice, legal deadline: none; no conclusion listed. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964. Checked October 19, 2026.
  3. Lim D. Peptide group to meet with White House over pending regulatory plan. Semafor, October 19, 2026, 4:59 AM ET (AAPM “is slotted to meet with the Office of Management and Budget on Wednesday”; Alliance for Pharmacy Compounding CEO Scott Brunner: “we don’t yet know what the policy says, which peptides it covers, or what conditions FDA may attach”). https://www.semafor.com/article/10/19/2026/peptide-group-to-meet-with-white-house-over-pending-regulatory-plan. Checked October 19, 2026.
  4. @himshouse on X, October 19, 2026, 7:16 AM ET: “BREAKING: The American Academy of Peptide Medicine (@LeeRosebush) is scheduled to meet with the Office of Management and Budget on Wednesday @ 3pm to discuss the pending peptide regulation $HIMS” (3,182 impressions when pulled). https://x.com/himshouse/status/2112140829225586980. Checked October 19, 2026.
  5. Executive Order 12866, Regulatory Planning and Review, September 30, 1993, section 6(b)(4): an agency representative “shall be invited to any meeting between OIRA personnel and such person(s)”; written communications are forwarded to the agency within 10 working days; OIRA “shall publicly disclose relevant information about such communication(s).” https://www.archives.gov/files/federal-register/executive-orders/pdf/12866.pdf. Checked October 19, 2026.
  6. American Academy of Peptide Medicine. About AAPM (“Est. 2025”; “official nonprofit academic society”; pillars “Policy Advocacy” and “Legitimacy & Safety Standards,” the latter listing “Pharmacy compounding standards” and “PCAC partnership”; leadership Dr. Pradeep Albert, Chief Medical Officer, and Lee Rosebush, PharmD, JD, MBA, Chairman & Chief Pharmacy Officer, “Chairman of the Outsourcing Facilities Association”). https://www.pepmed.org/about. Checked October 19, 2026.
  7. American Academy of Peptide Medicine. Advisory Board & Partners. Government board: Gov. Phil Bryant, Gov. Ricardo Rosselló, Lee Rosebush, Charles Meeker (Hyagen Medical), Michael Boes (Steak ’n Shake; former HHS senior advisor), Alex Hardy (MAHA Holdings), Kristen Gullott (Dogwood Strategies), Brigham Buhler (Ways2Well), Jimmy St. Louis (Agentis Longevity; Personalized Health Association). Medical board: Alex Tatem, James Lin, Matt Cook, Pradeep Albert, Danese Rexroad (Ways2Well), James LaValle (chair, International Peptide Society). Industry board: Jay Bhaumik (Thesis Pharmacy, BMK Pharma), Shaun Noorian (Empower Pharmacy, “a leading producer of compounded peptide therapies”), Dan DeNeui (EVEXIAS Health Solutions), Nate Hill (Strive Pharmacy). Partners: Ivím Health (“Premier Telehealth Provider”), CRE8 Pharmacy, Thesis Pharmacy, Empower Pharmacy, EVEXIAS Health Solutions, Noom; academic partner Lake Erie College of Osteopathic Medicine. https://www.pepmed.org/advisory-board. Checked October 19, 2026.
  8. Pradeep Albert, MD, personal site: “CEO, Vesalius Longevity Labs, Peptide distribution & longevity services”; “Founder, American Academy of Peptide Medicine”; founder and executive director of AAPM per the About page. https://www.drpradeepalbert.com/; https://www.drpradeepalbert.com/about. Checked October 19, 2026.
  9. PepMed 2026, Regenerative Health World Congress (AAPM), Washington, DC, September 17–18, 2026; “Draft lineup — speakers confirmed on a rolling basis.” Listed: keynote Rep. Diana Harshbarger (“Featured Keynote: A Pharmacist in Congress”); Adm. Brian Christine, MD, HHS Assistant Secretary for Health; Calley Means, HHS senior adviser; Timothy D. Fensky, “The Peptide Council” (panel “What’s Next for Compounding: From Bulks List to Bench”); Shaun Noorian (Empower), Nate Hill (Strive), Geoff Cook (CEO, Noom) and Taylor Kantor (Ivím Health) (panel “How to Do Peptides Right”). https://congress2026.pepmed.org/. Checked October 19, 2026.
  10. Outsourcing Facilities Association press release, October 8, 2024: OFA sues FDA over removal of tirzepatide from the drug shortage list (Lee H. Rosebush, Chairman of OFA: removal “is the definition of arbitrary and capricious”). https://www.businesswire.com/news/home/20241008699576/en/Outsourcing-Facilities-Association-Sues-FDA-Over-Sudden-Removal-of-Tirzepatide-from-Drug-Shortage-List; FDA declaratory order, December 19, 2024, footnote 2 (Outsourcing Facilities Ass’n v. FDA, No. 4:24-cv-953, N.D. Tex.; remanded October 11, 2024; FDA again found the shortage resolved). https://www.fda.gov/media/184606/download; Bloomberg Law, judge rules for FDA and Lilly (2025). https://news.bloomberglaw.com/health-law-and-business/fda-eli-lilly-score-win-in-weight-loss-drug-shortage-decision. Checked October 19, 2026.
  11. FDA. Pharmacy Compounding Advisory Committee meeting roster, July 23–24, 2026 (standing voting members including Gabriel Alizaidy, Maximus Health; Asare B. Christian, Aether Medicine; Timothy D. Fensky, National Association of Boards of Pharmacy representative; Sen. Bobby Harshbarger, PharmD, Premier Pharmacy Inc, Kingsport, TN; Melissa Loseke, Re-new Institute; Haleem Mohammed, Gameday Health; David Pope, Xifin Pharmacy Solutions; Elizabeth Rebello, MD Anderson; Brian Serumaga, USP representative, acting chair; Joshua Starbuck, Makena Health; Kris H. Wusterhausen, The Resurge Clinic; plus temporary voting members). https://www.fda.gov/media/193772/download. Checked October 19, 2026.
  12. PeptideBase. FDA Peptide Compounding Vote Tracker, PCAC July 2026: member-level ballots for 8 roll-call votes, “transcribed from meeting-room photos and the live webcast and may contain minor errors”; Day 2 results provisional pending the FDA transcript. https://peptidebase.io/fda-vote-tracker. Jabbit cross-checked each member’s blank cells against the topic limits on FDA’s roster [11]; all matched. Totals by group (Jabbit): members new in 2026, 60 yes, 1 no, 1 abstention; all others, 0 yes, 44 no, 8 abstentions. Data: ops/data/peptide-lobby/pcac-ballots-2026-07.json. Checked October 19, 2026.
  13. Jenkins JA. FDA’s peptide push draws questions. Law Street Media (FOIAengine), August 2026 (nominations withdrawn by Wells Pharmacy Network and LDT Health Solutions, “the latter acting on behalf of the International Peptide Society”; “seven of the eight new members had ties to peptide-related businesses and clinics”; “not a single holdover or temporary member voted in favor of any of them”; Rosebush “an attorney who has represented compounding pharmacies in litigation challenging the FDA restrictions”). https://lawstreetmedia.com/insights/fdas-peptide-push-draws-questions/. Checked October 19, 2026.
  14. Cunningham PW. FDA advisers with ties to the peptide industry recommend unapproved peptides. NOTUS, July 24, 2026 (Kennedy “appointed eight of the panel’s 19 members, all of whom voted to expand access to peptides. Six of those members run clinics that sell peptides”; Rosebush: “The committee weighed the evidence, followed the science and stood up for medical freedom”). https://www.notus.org/healthcare/fda-advisers-recommend-unapproved-peptides. Checked October 19, 2026.
  15. Wikipedia. Diana Harshbarger (“Her only son, Bobby Harshbarger, is currently the Republican state Senator for Tennessee’s 4th Senate district”; she and her husband “operate Premier Pharmacy, a compounding pharmacy”; sourced to WJHL and Kingsport Times-News). https://en.wikipedia.org/wiki/Diana_Harshbarger. Checked October 19, 2026.
  16. Dr. Alex Tatem (@DrAlexTatem) on X, October 18, 2026, 12:28 PM ET: “The American Academy of Peptide Medicine and its sister organization, the Peptide Council, are finalizing the COAs and monographs for each of the 6 voted on in the July PCAC.” https://x.com/DrAlexTatem/status/2111857029879083514; The Peptide Council accreditation site (“Accreditation for 503A Compounders and 503B Outsourcing Facilities”; describes itself as “A 501(c)(3) council”): https://www.pharmacyaccreditation.com/. Checked October 19, 2026.
  17. FDA Warning Letter 738238 to Empower Clinic Services, LLC dba Empower Pharmacy, Houston, TX, September 18, 2026, addressed to Mr. Noorian (inspection November 3–14, 2025; compounded TIRZEPATIDE/NIACINAMIDE and SEMAGLUTIDE/CYANOCOBALAMIN “essentially copies” of FDA-approved products “regularly and in inordinate amounts”; “significant difference” statements “repeated verbatim across many records, suggesting that they may be pre-generated”; sterile products made under insanitary conditions, including inadequate smoke studies and media fills; some corrective actions “appear adequate,” others deficient or not fully documented). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026. Checked October 19, 2026.
  18. FDA Warning Letter 700964 to Empower Clinic Services, LLC dba Empower Pharmacy, April 2, 2025 (inspection September 24–October 4, 2024; environmental monitoring did not sample the critical aseptic area; media fills not under worst-case conditions; stopper-handling equipment in the ISO 5 area not sterilized). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-700964-04022025. Checked October 19, 2026.
  19. Ivím Health home page (“12 months of compounded Tirzepatide $117 per month”; “12 months of compounded Semaglutide $65 per month”; “Dr. Jessica Duncan testified before the FDA to advocate for peptide access”). https://www.ivimhealth.com/; Noom Microdose GLP-1 Rx (“Compounded semaglutide available through Noom-GLP1ᴿˣ … has not been reviewed by the FDA for safety, efficacy, or quality”). https://www.noom.com/med/microdose-glp1-rx/. Checked October 19, 2026.
  20. Medscape. FDA expert panel backs compounding of six peptides, July 2026 (Rosebush told the committee that under the bulks rules “there’s no requirement to prove safety or efficacy”; compounded drugs are not FDA-approved and “there’s no requirement to report adverse events”). https://www.medscape.com/viewarticle/fda-expert-panel-backs-compounding-six-peptides-2026a1000pgw. Checked October 19, 2026.
  21. Stone W. Restrictions could be lifted on peptides loved by wellness influencers. NPR via Maine Public, July 6, 2026 (Rosebush: FDA “taking away access to these peptides via pharmacies who actually do testing … opened up a gray and black market”; he “represents peptide makers and sued the FDA”; ISMP’s Rita Jew: “When you have not established effectiveness, then the only thing you have is risk”). https://www.mainepublic.org/2026-07-06/restrictions-could-be-lifted-on-peptides-loved-by-wellness-influencers. Checked October 19, 2026.
  22. Bandelin L. RFK Jr.’s priority plan to put peptides in pharmacies pushed to White House. Daily Caller, October 16, 2026 (Rosebush: “We urge HHS and FDA to place these substances on the interim bulk drug substances lists”; Rosebush and Brigham Buhler co-authored “The Peptide Revolution”; Kennedy’s April 15, 2026 post on removing 12 withdrawn peptides from Category 2). https://dailycaller.com/2026/10/16/rfk-jr-peptides-pharmacies-hhs-action-plans/. Checked October 19, 2026.
  23. Piatkowski T, et al. Drug Alcohol Rev. 2026 (first published lab test of gray-market retatrutide: three vials labelled 10 mg held 5.13, 16.5 and 19.0 mg). Summarized with full citation in Jabbit’s retatrutide review: https://jabbitapp.com/peptides/retatrutide.html. Checked October 19, 2026.

This page summarizes public records: the White House regulatory review log, FDA rosters and warning letters, the organizations’ own websites and news reports. Descriptions of people and companies are taken from those sources, which are cited. It is not medical or legal advice.